Back to resultsBehavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
Primary Purpose
Persistent Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation for return to work
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Depressive Disorder focused on measuring Chronic depression, Dysthymic disorder, Double Depression, Behavioral Activation therapy, Work impairment, Unemployment
Eligibility Criteria
Inclusion Criteria:
- adults aged 20-75 years
- a primary diagnosis of Dysthymic Disorder, Chronic major depressive disorder or double depression
- a >50% decrease in 17 item Hamilton Rating Scale for Depression (HRSD-17) score and a final HRSD-17 score ≤ 10 with an adequate antidepressant medication (ADM) trial (> 4 weeks on at least 50% Physician's Desk Reference maximum ADM dose)
- a rating of 1 ("very much improved") or 2 ("much improved") on the Clinical Global Impressions-Improvement scale (CGI-I)
- continued functional impairment, defined by scores >1.9 on the Social Adjustment Scale (SAS)
- unemployment (jobless, looking for work) according to the Bureau of Labor Statistics: jobless and looking and available for work, or underemployed.
Exclusion Criteria:
- Structured Clinical Interview for Diagnostic and Statistical Manual, fourth edition (DSM-IV) Axis I disorders-diagnosed cognitive or psychotic disorders
- bipolar disorder
- active eating disorders
- severe borderline personality disorder
- alcohol or drug dependence (except nicotine) in the last 6 months
- current suicide risk
- unstable medical conditions
- use of psychotropic medications other than antidepressants
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioral Activation for Return to Work
Arm Description
BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Outcomes
Primary Outcome Measures
Paid Work Hours at Week 12
Subject-reported paid work hours per week at week 12
Paid Work Hours at Week Baseline
Subject-reported paid work hours per week at week baseline
Secondary Outcome Measures
Social Functioning at Week Baseline on the Social Adjustment Scale
Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning
Social Functioning at Week 12 on the Social Adjustment Scale
Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning
Full Information
NCT ID
NCT01783080
First Posted
January 25, 2013
Last Updated
April 4, 2017
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT01783080
Brief Title
Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
Official Title
Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators aimed to assess the ability of a modified version of Behavioral Activation for occupational and social improvement to produce change in: 1. social adjustment, 2. work functioning, 3. avoidance behavior and 4. behavioral activation.
Detailed Description
Psychosocial functioning was assessed before and after BA treatment in medication responsive depressed individuals who continued to have impaired social functioning. The primary goal was to demonstrate feasibility of recruitment and retention, and obtain an open pilot sense as to whether there are benefits from this brief psychotherapy approach in this population. The investigators also planned to refine measures and estimate the effect size of any treatment response to estimate power and sample size with the goal of completing a future controlled study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Depressive Disorder
Keywords
Chronic depression, Dysthymic disorder, Double Depression, Behavioral Activation therapy, Work impairment, Unemployment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Activation for Return to Work
Arm Type
Experimental
Arm Description
BA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation for return to work
Intervention Description
See Arm Description
Primary Outcome Measure Information:
Title
Paid Work Hours at Week 12
Description
Subject-reported paid work hours per week at week 12
Time Frame
Week 12
Title
Paid Work Hours at Week Baseline
Description
Subject-reported paid work hours per week at week baseline
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Social Functioning at Week Baseline on the Social Adjustment Scale
Description
Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning
Time Frame
baseline
Title
Social Functioning at Week 12 on the Social Adjustment Scale
Description
Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults aged 20-75 years
a primary diagnosis of Dysthymic Disorder, Chronic major depressive disorder or double depression
a >50% decrease in 17 item Hamilton Rating Scale for Depression (HRSD-17) score and a final HRSD-17 score ≤ 10 with an adequate antidepressant medication (ADM) trial (> 4 weeks on at least 50% Physician's Desk Reference maximum ADM dose)
a rating of 1 ("very much improved") or 2 ("much improved") on the Clinical Global Impressions-Improvement scale (CGI-I)
continued functional impairment, defined by scores >1.9 on the Social Adjustment Scale (SAS)
unemployment (jobless, looking for work) according to the Bureau of Labor Statistics: jobless and looking and available for work, or underemployed.
Exclusion Criteria:
Structured Clinical Interview for Diagnostic and Statistical Manual, fourth edition (DSM-IV) Axis I disorders-diagnosed cognitive or psychotic disorders
bipolar disorder
active eating disorders
severe borderline personality disorder
alcohol or drug dependence (except nicotine) in the last 6 months
current suicide risk
unstable medical conditions
use of psychotropic medications other than antidepressants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J Hellerstein, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21586994
Citation
Erickson G, Hellerstein DJ. Behavioral activation therapy for remediating persistent social deficits in medication-responsive chronic depression. J Psychiatr Pract. 2011 May;17(3):161-9. doi: 10.1097/01.pra.0000398409.21374.ab.
Results Reference
background
PubMed Identifier
25464836
Citation
Hellerstein DJ, Erickson G, Stewart JW, McGrath PJ, Hunnicutt-Ferguson K, Reynolds SK, O'Shea D, Chen Y, Withers A, Wang Y. Behavioral activation therapy for return to work in medication-responsive chronic depression with persistent psychosocial dysfunction. Compr Psychiatry. 2015 Feb;57:140-7. doi: 10.1016/j.comppsych.2014.10.015. Epub 2014 Nov 7.
Results Reference
result
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Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
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